Specialist

2 weeks ago


Vadodara, Gujarat, India beBeeData Full time ₹ 8,00,000 - ₹ 12,00,000
Job Description

We are seeking a skilled and detail-oriented specialist to contribute to the quality and compliance of our IT systems, particularly in the pharmaceutical and healthcare domains.

The ideal candidate will deliver high-quality validation documentation, ensure timely execution of validation tasks, and maintain strong alignment with industry standards.

Key Responsibilities:
  1. Data Specialist: Ensure compliance with regulatory requirements by developing and maintaining protocols and reports.
  2. Cross-Functional Collaboration: Deliver high-quality CSV documentation with strict adherence to timelines and quality standards.
  3. Technical Documentation: Prepare user manuals, SOPs, and other technical documentation related to data processes.
  4. Data Activities: Conduct risk assessments, validation testing, and documentation review to ensure data integrity.
  5. Audit Support: Provide relevant documentation and participate in audit response efforts to maintain data compliance.
  6. Regulatory Updates: Stay informed about current best practices and align company practices accordingly.
  7. Training and Development: Train internal teams and stakeholders on data processes and expectations.
  8. Process Improvement: Enhance data processes and document efficiency for continuous improvement.
  9. Record Maintenance: Maintain accurate records of all data-related activities and projects.
  10. Expert Guidance: Provide expert guidance to internal departments and stakeholders as required.
Requirements:
  • Bachelor's degree in Computer Science, Engineering, or a related field.
  • Proven experience in data within regulated industries like pharmaceuticals or healthcare.
  • Strong understanding of GxP compliance, FDA guidelines, and related industry standards.
  • Exceptional communication skills with the ability to produce clear, concise, and structured documentation.
  • Detail-oriented, with excellent analytical and problem-solving skills.
  • Capable of working independently as well as collaboratively in a team environment.
  • Flexibility to travel for client visits or perform remote validation execution as needed.


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